Psychiatric medications, science, marketing, psychiatry in general, and occasionally clinical psychology. Questioning the role of key opinion leaders and the use of "science" to promote commercial ends rather than the needs of people with mental health concerns.

Friday, June 12, 2009

Story one: Zachary Stowe, psychiatrist at Emory University becomes Charles Nemeroff, Jr. Read all about it the Carlat Psychiatry Blog and University Diaries. And check out the WSJ Health Blog as well. The gist is that Stowe apparently did not report all of his external income from his many pharmaceutical industry gigs. Better yet, he was a frequent speaker for GlaxoSmithKline, which had the gall to cancel two of his commercial talks. He then wanted GSK to pay him even though he wasn't going to give the speeches. Read the relevant emails toward the bottom of this document. After reading about Stowe, refresh your memory about Golden Goblet Lifetime Achievement Award Winner, former Chair of Psychiatry at Emory University: Charles Nemeroff. Is there something in the water at Emory? Or is that just how we roll in modern academic psychiatry? Stowe is hereby nominated for a coveted Golden Goblet for his string of emails in which he attempted to shake down GlaxoSmithKline. Sometimes I think that the only thing worse than drug companies are the narcissistic academics who they employ as "key opinion leaders." Not all key opinion leaders are jerks; some are probably even able to reasonably balance their industry cash with being good scientists. But Stowe didn't really portray himself as Mr. Nice Guy in his string of soon to be infamous emails.

"Especially disturbing is an email between employees at GSK and a public relations (PR) firm that the GSK hired. The email was titled “For your review/Paxil Breast Milk Press Release” and states:

"[P]lease review the attached press release and forward me any comments/edits.As you may know, Dr. Stowe is on board for publicity efforts and NAMEREDACTED and I are coordinating time to meet with him next week to arm himwith the key messages for this announcement, which is slated for early February.We are sending the release for your review at the same time in efforts to securedistribution on Emory letterhead (as you know, would provide further credibilityto data for the media)."

In his testimony, Dr. Stowe confirmed that the press release was written by the PRfirm and concerned his research on Paxil and its presence in breast milk. He alsoexplained that placing the press release on Emory letterhead, as opposed to GSK letterhead, would make the data more credible to the public."

If I have this straight, Stowe was willing to place a press release written by a PR firm hired by GSK on official university letterhead to enhance its credibility. Apparently he wasn't concerned about his own credibility. Read the full document of Senator Charles Grassley's investigation of Dr. Stowe.

Ensuring that medical journal articles presented Zyprexa study results in a positive light was one way for Lilly to reach its sales goal, company officials said in its plan, according to the documents. To do that, Lilly officials hired ghostwriters to prepare submissions to journals such as Progress in Neurology and Psychiatry, according to the unsealed documents. “The paper for the Progress in Neurology and Psychiatry supplement has been completed and sent to the journal for peer review,” Kerrie Mitchell, an employee of the public relations agency Cohn & Wolfe, wrote in a Feb. 23, 2001, e-mail to Michael Sale, a Lilly marketing official. The message was among the unsealed files. “We ‘ghost’ wrote this article and then worked with author Dr. Haddad to work up the final copy,” Mitchell said in the e- mail. Eric Litchfield, a spokesman for Cohn & Wolfe, didn’t immediately return a call requesting comment.

The Bloomberg story is based on a recently released set of internal Lilly documents. That's right -- more Zyprexa documents are on the loose. And the first round of documents provided some good stuff (1, 2, 3), so I can't wait to see what kind of chicanery will be revealed by the latest round. In one sense, it's not exactly news that Lilly ghostwrote Zyprexa papers. We all know that ghostwriting is rampant. How else do key opinion leaders get their names on dozens of papers per year when they are also flying around the country pimping drugs, holding administrative meetings, and doing all sorts of other tasks? But it's nice to have it officially documented that Lilly was playing the ghostwriting game with Zyprexa.

7 comments:

Barton Moffatt, a Mississippi State University bioethicist who has written about ghostwriting practices among drugmakers, said there’s a growing consensus that doctors who lend their names to such articles are engaging in “academic misconduct.”“No one has been fired yet over this, but I think the trend is moving in that direction,” Moffatt said. “I think over the last 15 to 20 years, putting your name on a ghostwritten article has come to be seen as plagiarism.”_____________________________________________________________________________

Is this some kind of joke? Putting your name on an article you did not write, and, in many cases, barely reviewed, requires some actual deliberation as to whether it is plagiarism and academic misconduct? We need to form a consensus body to derive that conclusion?

Unbelievable indeed. Putting your name on a paper you didn't write, often for a study you weren't involved with is grade A academic misconduct. I particularly like ghostwritten review articles, but any ghostwritten stuff needs to be acknowledged as such. And not just with some teeny little notice of "editorial assistance." But that would sort of kill the point of ghostwriting.

Students fail classes and get kicked out of college for this type of thing, but if a professor/academic does it, then it's apparently perfectly acceptable.

I have to say I'm not sure that ghostwriting per se is the main issue - I mean, presumably this PR firm wrote a paper about Zyprexa that was biased in Zyprexa's favor. That's the problem, not the fact that a PR firm wrote it.

Granted the paper probably got some extra credibility because it seemed to come from a "key opinion leader" - but the very fact that it was published in a peer-reviewed journal gives it a lot of credibility in itself.

What I'm saying is that this is a failure of peer-review, at least as much as it's a failure on the part of the writers. A paper that's unreasonably favorable to a drug shouldn't get published, whoever wrote it (and academics are perfectly capable of writing such papers with no help!)

I left the Emory Department of Psychiatry in the mid-1980's when the era of 'medicalized psychiatry' came upon us in the form of a new chairman. He moved up to become Dean in a few years and was replaced by Dr. Nemeroff and his cadre of "drug trial researchers." The stuff that everyone is so bent out of joint by has been going on since he came [1991].

I've been to a few of those "talks" over the years. It's hard to imagine that anyone in the audience didn't get that they were little disguised ads for some drug du jour. And it's equally hard to imagine that so many of the psychiatrists they've trained spend their time prescribing medications based on a symptom grid and the kind of information in those talks and articles.

While the focus of the Nemeroff/Stowe and other scandals is the deceit in not revealing their large corporate incomes, the long term damage is the trivialization of psychiatry into a specialty focused on one specific treatment modality rather than the breadth of mental illness itself.

When they came, they claimed they were bringing "science" to psychiatry. That's not the way it turned out...

I agree that the various highly flawed puff pieces that are so often published as review articles or clinical trial findings are a quite obvious symptom of highly lax editorial oversight and/or a broken peer review system. A bad paper is a bad paper, regardless of authorship.

Former Emory Prof,Thanks for chiming in. The lack of reporting incomes is really small potatoes in comparison to doing some really bad science. But Grassley, journalists, and others tend to not have much training in research design, so it's easier to pick on the lack of reporting income. The bad science certainly causes much more trouble than the hidden conflicts of interest.

We are discussing two distinct but related ethical problems. The fact that the article was biased in favor of olanzapine is another data point -- as if any more were needed -- that the exchange of money that surrounds clinical research can and does have an effect on virtually every aspect of the design itself, and that these influences frequently do not redound to the benefit of those who will be using the products under evaluation. This is one ethical problem.

The second ethical problem is one of publication ethics; whether the ethical breach that attends signing one's name to a piece of writing one did not complete according to ICJME standards is "less of a problem" obviously fails to show it is not a problem at all.

To the contrary, the best evidence suggests that standards of publication ethics -- and more than standards, the key ethical values that justify beliefs about best practices -- are observed in the breach. Better science is of course always needed, but some, like myself, believe that the actual commitment to excise plain ethical violations in publications may frustrate the problem, because they contribute to a culture in which research integrity is deemphasized. So, while I realize you may not be committed to this point itself, I would be wary of suggesting that publication ethics are less important than the conduct of the research. The two are distinct, but may be in some respects mutually inclusive or exclusive.

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About Me

I'm an academic with a respectable amount of clinical experience and no drug industry funding. Given my lack of time, don't expect multiple daily updates. Certain things about clinical psychology, the drug industry, psychiatry, and academics drive me nuts, and you'll probably pick up on these pet peeves before long...